Boots 56-90-447

Device Name:56-90-447
Manufacturer:OBL: Boots, PO Box 5300, Nottingham, NG90 1AA, UNITED KINGDOM.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Boots 56-90-447, to measure blood pressure, has been compared to a validated device but the results of the study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Relevant Publications

Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.

Measurements from the Boots 5690447 are compared to those from the Omron BPM tester PA-350, though not in a formal validation.

Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

Omron M2 Compact (HEM-7102-E)

Asmar R, Khabouth J, Topouchian J, El Feghali R, Mattar J. Validation of three automatic devices for self-measurement of blood pressure according to the International Protocol: The Omron M3 Intellisense (HEM-7051-E), the Omron M2 Compact (HEM 7102-E), and the Omron R3-I Plus (HEM 6022-E). Blood Press Monit. 2010 Feb;15(1):49-54. doi: 10.1097/MBP.0b013e3283354b11. PMID: 20032779.

ESH-IP:2002 - Pass General population

Omron MX3 Plus (HEM-742-E)

Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron MX3 Plus oscillometric blood pressure monitoring device according to the European Society of Hypertension international protocol. Blood Press Monit. 2005 Jun;10(3):165-8. PMID: 15923819.

ESH-IP:2002 - Pass General population

Christofaro DG, Casonatto J, Polito MD, Cardoso JR, Fernandes R, Guariglia DA, Gerage AM, de Oliveira AR. Evaluation of the Omron MX3 Plus monitor for blood pressure measurement in adolescents. Eur J Pediatr. 2009 Nov;168(11):1349-54. Epub: 2009 Feb 17. doi: 10.1007/s00431-009-0936-x. PMID: 19221789.

BHS:1993 - Pass (A/A) General population

SP10:1996 - Pass General population